This role is responsible for executing and developing bioassays to support AskBio's AAV gene therapy programs from early-stage method development through GMP qualification
Job Summary
This role is responsible for executing and developing bioassays to support AskBio's AAV gene therapy programs from early-stage method development through GMP qualification.
The successful candidate will independently design, troubleshoot, and optimize cell-based potency assays, immunoassays, and molecular assays while authoring technical documentation for regulatory submissions.
AskBio is dedicated to pioneering science to create transformative molecular medicines with a mission to lead innovative science and drive clinical outcomes.
Matching Summary
This role is responsible for executing and developing bioassays to support AskBio's AAV gene therapy programs from early-stage method development through GMP qualification.
Skills & Requirements
Must-have
PhD in molecular biology or related field
Hands-on cell-based bioassay experience
Proficiency in ELISA, MSD, ddPCR, qPCR
Mammalian cell culture techniques
Method development through qualification
GMP regulatory compliance knowledge
Nice-to-have
AAV viral vector characterization experience
IND-enabling or BLA-stage program support
Parallel line analysis statistical skills
ICH Q2 and ICH Q14 guideline familiarity
Mentoring junior laboratory staff
Key Requirements
Ph.D. in molecular biology, biochemistry, cell biology, virology, or related discipline
Minimum 2 years of industry experience with Ph.D. or 8+ years with Master's degree
Onsite work requirement at Research Triangle Park facility